Pediatric ventilation mask and headgear system

Abstract

A nasal or full-face mask and headgear system for improving pediatric compliance of ventilation therapy, including CPAP or BiPAP, and sized for pediatric use is provided. Each mask has a shallow concave rigid shell bearing the visage of a caricature. Unique caricatures are predetermined to represent different sizes of masks. Further, headgear is provided in keeping with the caricature theme and having additional aspects such as ears, removably attached to it. Each mask has an inner inflatable cuff to improve fit and an outer replaceable cuff to facilitate cleaning as well as fitting. The headgear is attached to the mask at three contact points using straps having key slots attached to ends of the straps and raised buttons on the mask shell. The straps are adjustable for length using Velcro™ and are not adjusted each time the system is placed onto the patient, improving positioning of the mask when the patient is asleep or resistant.

Description

FIELD OF THE INVENTIONThe present invention relates to apparatus used in the field of non-invasive and invasive ventilation therapies including continuous positive airway pressure (CPAP) or bi-level positive air pressure (BiPAP) therapy and particularly to nasal and full-face masks and headgear used to treat pediatric patients.BACKGROUND OF THE INVENTIONContinuous positive airway pressure (CPAP) or alternatively, Bilevel Positive Airway Pressure (BiPAP) have become conventional forms of non-invasive ventilation treatment for adult patients suffering from obstructive sleep apnea and other nocturnal breathing disorders. Furthermore, not only has it been shown to be an effective therapy, but there is also evidence that it contributes to less time in hospital, fewer medical complications and decreased mortality compared to immediate intubation and ventilation.Continuous positive airway pressure (CPAP) is delivered by a positive airway pressure generator into a mask worn by the patient w...

AI Technical Summary

Benefits of technology

The mask and headgear system of the present invention alleviates the problems associated with patient compliance during ventilation therapy such as CPAP or BiPAP therapy. The caricatures represented on both the mask shell and on the headgear create a fun, readily accepted apparatus that is not viewed by the pediatric patient as merely another intrusive medical device.

Further, the association of each unique caricature with a particular predetermined size assists the therapist in rapid identification and fitting of the mask and headgear to the patient. This is of particular advantage when a wider range of pediatric sized masks are provided for improving fit-matching and which may only differ by small increments that are not readily discerned visually. Further, proper size selection improves comfort and fit with increased likelihood of compliance.

More preferably, the invention comprises a unique mask having a concave shell which is suitable for fitting over the nose or nose and mouth of a pediatric patient. The concave profile of the shell permits sufficient room for the patient's nose so that it does not rest on the shell, reducing the incidence of pressure sores. Further, the concave shape permits greater air movement without an increase in dead space within the interior of the mask.

The mask provides both an outer replaceable cuff and an inner inflatable cuff. The outer cuff protects the inner cuff from contact with the patient's face and can be easily removed for cleaning or replacement with a cuff having a different size of opening for the nose or nose and mouth. The inner cuff can be inflated to varying degrees to provide a wider range of profiles suitable for sealing against individual patient's faces to provide an optimum fit within a single mask size. The inner cuff when inflated, positions the shell further away from the patient's nose and cheeks allowing more room for the nose. Further, in patients such as those with Down's Syndrome, in which there is relatively little, if any, nasal bridge, inflation of the interior cuff aids in preventing the mask from slipping up towards the patient's forehead. When deflated, the mask has a flatter profile, the shell being positioned closer to the nose and cheeks, for permitting a better fit for individual patients.

The above apparatus and methodology enables the provision of a mask and a system which is particularly useful in the treatment of pediatric cases. Accordingly, a broad system is provided for improving compliance in a pediatric population for the use of ventilation masks and headgear and providing size recognition comprising: a plurality of masks and headgear of predetermined known matched and serial sizes so as to fit a range of pediatric patients wherein the mask further comprises a concave shell; at least one flexible cuff attached about a periphery of the shell and having an opening for receiving a patients nose or nose and mouth; a port in the shell for receiving tubing for attachment to a ventilation device; at least one exhalation port; and means for attachment to the headgear; and the headgear comprises a cap and a plurality of straps having means for attachment to the mask; and a size indicator being a predetermined visage of a caricature, preferably animals, represented on each of the plurality of masks, each caricature being predetermined to represent one of each of the plurality of sizes.

Problems solved by technology

This effectively dilates the upper airway, preventing its collapse, thus enabling the patient to assume a normal breathing pattern which results in an uninterrupted sleep.

It can be extrapolated however, that these issues are also present for the pediatric patient and, in many cases, are made worse due to the patient's lack of understanding of the therapy and fear of intervention, as well as the commercial unavailability of a wide variety of sizes or well fitting masks and headgear.

Approximately 20% of patients, for a variety of reasons, never learn to tolerate it and a substantial proportion of the others have a hard time using it regularly.

The statistics for use in pediatric patients can be much worse.

Problems such as mask fit, pressure sores or redness around the nose and nasal dryness or stuffiness are common reasons that patients fail to comply.

Air leaking from around a poorly fitting nasal mask can be quite uncomfortable and possibly result in suboptimal treatment.

Air leaking causes the generator to blow more air to achieve the prescribed pressure, thus making it more uncomfortable for the patient and possibly causing more arousals during sleep.

For this reason, it is essential that the mask fit properly, which is particularly challenging in the case of children.

Clearly nasal and full-face masks designed to fit the adult face are unsuitable for these patients, especially in their early years.

Craniofacial abnormalities may add to the difficulty in finding a mask that fits well.

Further, it has been reported that children wearing an improperly fitting mask during bone development can develop facial abnormalities as a result of the poorly fitting mask.

Nasal prongs or nasopharyngeal tubes, that may be used in a hospital setting to deliver CPAP, are not available for equipment designed for the home environment.

Often, a suitable component is not available at all and the therapist and patient must “make do” with the closest alternative, which is often uncomfortable and heavy and as a result little used.

Once the cuff has been cut to provide a better fit for slightly larger noses or abnormalities, the cut edges are likely to cause irritation at the points of contact or leaks where there is insufficient sealing.

Further, the cushioned forehead support continues to cause pressure sores, especially in the smallest of the patients where the headgear may not fit adequately and the mask moves about.

For many patients, the flat surface of the mask shell does not permit adequate space for the nose and as a result the nose rests against the surface often resulting in pressure sores.

Many of the pediatric patients are non-compliant and may fall asleep periodically throughout the day and night.

The Velcro™ fasteners are difficult to adjust without arousing the child.

More importantly, if the child has fallen asleep in an awkward position, it is difficult to ensure that the mask is positioned correctly and snuggly on the face, as the length of the straps are dependant on where the fasteners are fastened each and every time the mask is worn.

Placing a mask on the face may elicit fear of the apparatus itself or what it is perceived to be associated with and particularly for those who have become tactile defiant, compliance becomes a struggle that many parents and therapists are unable to resolve.

For some patients, the loss of time may be critical to their overall health and may result in the need to proceed to more conventional invasive techniques such as tracheostomy, without giving the therapy a chance.

The aerosol mask however, cannot be used to administer CPAP, as it is designed to be hand held over the nose and mouth for short-term use for inhalation only, rather than attached to headgear for continuous use.

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